8/16/2016 Disclosures • Moderate Support (research) • Biosense Webster Is Durable PVI Enough for Ablation of Persistent AF? • Bayer Inc CHRS 2016, San Francisco • Boehringer Ingelheim • Medtronic Inc • Advisory Board, Speakers fees Atul Verma, MD FRCPC FHRS • Bayer Inc Director, Heart Rhythm Program • Biosense Webster Southlake Regional Health Centre • Boehringer Ingelheim Newmarket, Ontario, Canada Chair, Heart Rhythm Working Group, Cardiovascular Care Network • Medtronic Inc Associate Professor, University of Toronto • St Jude Medical Inc Adjunct Professor, McGill University Key Strengths of STAR AF II • Exclusively persistent AF (80% in continuous AF > 6 months) • Large clinical study (589 patients in 48 centers) • Rigorous follow ‐ up (18 months, Holters, at least weekly TTM for entire 18 months) • Arms chosen based on most common techniques of ablation for persistent AF: PVI, PVI+CFE, and PVI+LINES (1) 1 Calkins et al, Consensus Guidelines Catheter Ablation, Heart Rhythm 2012 1
8/16/2016 Purpose Methods – Ablation Strategy ** Complete elimination of CFE • To compare the efficacy of three different AF ablation (not defragmentation) until termination strategies in patients with persistent AF*: or all CFE regions eliminated. (1) Pulmonary vein isolation (PVI) alone CFE strategy (2) PVI plus complex fractionated electrograms (PVI+CFE) (3) PVI plus linear ablation (PVI+Lines). Linear strategy ** Pre ‐ specified pacing manoeuvres to determine linear block * Defined as AF episode lasting > 7 days but less than 3 years Results ‐ Ablation characteristics Results ‐ Primary Outcome Documented AF > 30 seconds after one procedure with or without AAD • 79% of patients presented to EP lab in spontaneous AF p=0.15 • Successful PV isolation obtained in 97% of all patients (all groups) • CFE were eliminated in 80% of patients 59% – 11% not ablated because AF non ‐ inducible after PVI 48% – 9% all CFE could not be eliminated 44% • Both lines with block achieved in 74% of patients – Roof line only 93% – Mitral line only 75% 2
8/16/2016 Percentage of Patients with PV AF Burden Reduction Recovery at Repeat Procedure 100 86 84 83 Patients with >1 recovered PV (%) 90 77 80 70 60 50 40 30 20 10 0 PVI PVI+CFE PVI+Lines Total Burden calculation based on maximum of burden calculated from all follow ‐ up Holters or # of weeks with at least one TTM of AF or number of days in AF from CRF * 80% of PVI+Lines pts also had gap in one or more lines, 63% of PVI+CFE had more CFE to ablate Freedom from AF/AT after 1 procedure Freedom from AF/AT after 1 procedure based on linear block achieved based on all CFE ablated 3
8/16/2016 13 14 CHASE AF Trial – Volger et al, JACC 2015 CHASE AF Trial • Randomized comparison of full stepwise approach (PVI+CFE+LINES) vs PVI alone + cardioversion for patients with persistent AF • All patients received PVI first – any patient terminating after PVI alone was excluded • The stepwise patients received: • 100% got LA defragmentation • 81% got CS defragmentation • 91% got RA defragmentation • 36% got linear ablation for AT 15 16 CHASE AF - Results Meta-Analysis – PVI or PVI+ for PeAF Scott et al, Europace 2016 ** Still no difference when multiple procedures taken into account 4
8/16/2016 17 18 Meta-Analysis – PVI+CFAE vs PVI Meta-Analysis – PVI+LALA vs PVI 19 20 Cryoballoon for Persistent AF Cryoballoon for Persistent AF • 100 patients undergoing ablation with Artic Front Advance balloon Over mean follow-up of technology with 11 +/- 6 months, persistent AF 67% of patients were in sinus rhythm • Follow-up at 1,3,6, and 12 months • 7 day Holter at 3 and 6 months and 24 hour Holter at 12 months Koektuerk et al, Circ EP 2015 5
8/16/2016 21 Does this prove that PVI is enough for persistent Cryoballoon for Persistent AF AF? • 393 patients undergoing • NO. ablation with Artic Front • Success rates are still low – about 60% in all of these Advance balloon studies technology • Many of these patients required more than one procedure • Only 62 (16%) had • We can and should be able to do better persistent AF • Better patient selection? • Success in 61.3% • Need to identify novel targets for ablation more effective • Persistent AF was one of than CFAE or linear ablation three multivariable predictors of recurrence Irfan et al, Europace 2015 24 AcQMap™ High Resolution Imaging and AcQMap of Pre-PVI AF Mapping System 48 LSPV Engineered • Pre-PVI map showed an even LSPV • Ultrasound anatomy reconstruction electrodes mix of focal breakthrough and RSPV RSPV LAA • Up to 115,000 points collected per LAA confined zones of irregular- LIPV minute 48 rotational conduction anterior RIPV Ultrasound • 3D surface is algorithmically transducers to the right PV antrum and reconstructed from ultrasound point between the inferior aspect of set MV right and left PV antrums. • Dipole density mapping LSPV LSPV LSPV RSPV RSPV LAA LAA RSPV LAA • Intracardiac unipolar voltage sampled • “Irregular rotational” refers at 150,000/sec LIPV LIPV LIPV to multidirectional spiral • Forward and inverse algorithms RIPV RIPV RIPV conduction around a applied to derive dipole density confined zone. • Multiple map types to view and assess activation patterns Identify and locate Image guided ablation arrhythmic mechanisms strategy Brief Summary: Please review the Instructions for Use prior to using these devices for a complete listing of indications, contraindications, AcQMap is not for sale in the United States warnings, precautions, potential adverse events and directions for use. 6
8/16/2016 26 NOVEL ALGORITHM OF DOMINANT FREQUENCY & ELECTROGRAM PATTERNS TO IDENTIFY FOCAL SOURCES AND ROTATIONAL PATTERNS DURING HUMAN PERSISTENT ATRIAL FIBRILLATION TOUCH AF Trial – Verma et al, pending AtulVerma, MD, FHRS, Thomas Deneke, MD, PhD, Yariv A. Amos, Msc, Roy Urman, BSc, Philipp Halbfass, MD, Karin M. Netwich, MD, Erik Wissner, MD, FHRS, Karl- Heinz Kuck, MD, FHRS and Roland, TilzMD. SOUTHLAKE REGIONAL HEALTH CENTRE, Newmarket, Ontario, Canada; HEART CENTER BAD NEUSTADT, Bad Neustadt, Germany; BIOSENSE WEBSTER , Haifa, Israel; ASKLEPIOS KLINIK ST. GEORG , Hamburg, Germany ABSTRACT RESULTS Focal Source Number of focal sources found • Contact force sensing for ablation of persistent AF in analysis of 121 maps Automated methods may identify areas of The CARTOFINDER™ system identified • Allowed wide antral PVI and roof line only interest during ablation of persistent atrial 34±14% of the basket EGMs were adequate fibrillation (AF). We sought to determine if an for analysis when positioned in the left atrium algorithm based on dominant frequency (DF) (LA) and 60±15% were adequate in the right and electrogram (EGM) patterns during atrium (RA). • Randomized operators to CF-guided vs CF-blinded persistent AF could be used to identify focal 20 patients were analyzed, rotational sources and rotational patterns . activations were identified by the experts in approach 27/70 (39%) of the LA maps and 24/51 (47%) of the RA maps. Focal sources were identified in 47/70 (67%) of the LA maps and METHODS 46/51 (90%) of the RA maps. Number of rotational activation wave front found • Final analysis not yet complete, BUT….. in analysis of 121 maps . Maps of persistent AF were acquired using a multi-electrode basket catheter. The CARTOFINDER™ Algorithm sensitivity and specificity CARTOFINDER™ algorithm filters all Rotational Activation Pattern with respect to human expert identification unipolar EGMs for quality, reduces far-field Foci Sensitivity/Specificity 89% / 77% ventricular artifacts and annotates the timing RAP Sensitivity / of the activation wave front. DF analysis was • Average contact force was 15 grams for both arms 82% / 70% Specificity performed and the pattern was classified as homogenous (<0.5 Hz) or heterogeneous Rotational activations covered 67±8% of the local CL with a mean of 3.0±2.7 rotations. (>0.5 Hz) & stable (regular/no variation over • Overall success rate was 78% with fewer than 20% of CONCLUSIONS 30 sec) or unstable (random variation). The Rotational wave front patterns were related algorithm can identify QS EGM patterns and to areas of homogeneous-stable DF “regular” sequential atrial activation spatiotemporal stability (variance 0.46± patients requiring second procedure A CARTOFINDER™ algorithm based on gradients occupying >50% of the cycle 0.17Hz) and with sequential EGM activation DF, LAT and EGM patterns correlated well gradients . Focal sources were related to length (CL) suggesting rotational wave with visually confirmed regions of interest fronts. All 4D activation maps were reviewed areas of heterogeneous-stable DF during human persistent AF. These spatiotemporal stability (variance by two blinded independent adjudicators to patterns could prospectively identify visually identify focal sources and rotational 0.58±0.30Hz) and with a consistent QS EGM regions of interest with a reasonably high pattern. DF temporal stability between RAPs wave fronts & only those agreed upon by predictive value. both reviewers were included for analysis. and sources was statistically significantly different (unpaired t test, p<0.000001) Conclusions • PVI seems to be the cornerstone for any ablation procedure for persistent AF • Success rates with PVI alone seem to be stuck around 60% • Many will require more than one procedure • Mapping AF may help us to realize novel targets for ablation and improve success rates 7
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